Introduction: Multiple studies have demonstrated the superiority of HoLEP in aspects such as transfusión rates or postoperative stay. On the other hand, no differences have been observed in terms of functional outcomes between both techniques, and surgical times reported in different studies tend to be longer for HoLEP. These results likely contribute to TURP, especially with bipolar energy (Bi-TURP), continuing to be considered by many the gold standard for surgical treatment of BPH.
Sofware and hardware upgrades to the Lumenis Pulse 120H. system in 2017, delivered MOSES 2.0, a single-use laser fibre used to perform MOSES augmented HoLEP (MoLEP). MoLEP has shown to be superior in intraoperative outcomes when compared to traditional HoLEP. The availability of new morcellators might also decrease surgical time for HoLEP. This changing landscape for BPH endoscopic surgery deserves a re-evaluation of the differences between Bi-TURP and MoLEP.
Primary Objective: To compare the hospital stay of patients of patients undergoing MoLEP with those undergoing Bi-TURP.
Secondary objectives:
* To compare the surgical time of MoLEP with that of Bi-TURP. * To compare the bladder catheterization time aCer MoLEP with that of Bi-TURP. * To compare the postoperative complication rate patients undergoing MoLEP with those undergoing Bi-TURP. * To compare functional results of patients undergoing MoLEP with those undergoing Bi-TURP.
This study is a prospective multicentric randomized and controlled trial. The study compares two types of BPH surgery without changing standard medical practice.
The study will include patients who are candidates according to standard medical practice for BPH surgery. Patients will be randomized to one of two groups of treatment.
* The MoLEP group will receive surgical treatment with MoLEP. * The Bi-TURP group will receive surgical treatment with Bi-TURP. Surgical technique and postoperative care will follow standard clinical practice at each participating centre.
Patients with maximum flow rate < 15 ml/sec before obstructive surgery or with maximum flow rate > 15 ml/sec and urodynamic study showing high-flow obstruction defined as bladder outlet obstruction index > 40.
Patients with moderate to severe lower urinary tract symptoms (LUTS) according to the International Prostate Symptom Score (IPSS). Score between 8 and 35.
Patients with a prostate volume between 40 and 80 cc, measured by urological ultrasound or MRI.
History of prior prostatic obstructive or urethral surgery.
Diagnosis of prostate neoplasia.
Diagnosis of urothelial neoplasia.
Lack of flowmetry or IPSS data before surgery.
Parallel
MoLEP
DevicePatients with an indication for surgery for BPH via EEAP with a prostate volume exceeding 80cc will be included in the study on a prospective basis. Surgery will be randomly assigned using MoLEP or BiTURP. A qualified surgeon, having completed their learning curve for endoscopic enucleation (more than 50cases) and possessing experience with both laser types, will perform the surgical procedure.
BiTURP
DevicePatients with an indication for surgery for BPH viaEEAP with a prostate volume exceeding 80cc will be included in the study on a prospective basis. Surgery will be randomly assigned using MoLEP or BiTURP. A qualified surgeon, having completed their learning curve for endoscopic enucleation (more than 50cases) and possessing experience with both laser types, will perform the surgical procedure.
Postoperative hospital stay
Variation in length of hospital stay after each procedure. Difference in postoperative hospital stay time between MoLEP and BiTURP. Number of hours in the hospital after the procedure if finished, organized in the following categories: Outpatient procedure (less than 16 hours), 1 day of hospitalization (≤ 24 hours), 2 days of hospitalization (≤ 48 hours), 3 days of hospitalization (≤ 72 hours). Individual length of stay will be recorded).
SURGICAL TIME
Difference in surgical time between MoLEP and BiTURP in prostates larger than 80 cc.
The bladder catheterization time
Difference in the bladder catheterization time after MoLEP with that of Bi-TURP
Perioperative complications
Difference in the incidence of perioperative complications between MoLEP and ThuFLEP. All possible complications will berecorded and classifi ed according to the Clavien- Dindo scale from date of surgery to end of study.
TREATMENT
Variation in treatment efficacy between groups. Difference in improvement after MoLEP compared to BiTURP
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